Validation Engineer Iii (Onsite)

Purpose and Scope

Support the commissioning, qualification and validation program through installation, operational, and performance qualification process equipment, laboratory instrumentation, facilities, and utilities, in addition to cleaning and computer systems validation, as applicable.

 Essential Duties & Responsibilities

• Support change management of qualified systems through impact assessments.
• Support development of the validation program through continuous improvement.
• Plan and coordinate validation activities for cross-functional projects, including but not limited to validation plans, protocols, and reports.
• Assist in commissioning activities, including, but not limited to development of requirements and specifications, risk assessments, and acceptance testing.

• Perform Commissioning, Qualification, and Validation (CQV) in the following areas, as applicable:
• Temperature mapping of warehouses and controlled temperature units
• Aseptic manufacturing equipment
• Non-sterile manufacturing equipment
• Utility systems
• Laboratory equipment and instrumentation
• Automated systems
• Sterilization processes (Autoclaves, Dry Heat Ovens, Process SIP, VHP)
• Cleaning validation
• Computer systems validation

• Participate and/or lead cycle development initiatives for overall efficiency.
• Interface with Engineering, Facilities, Regulatory, Quality, and Manufacturing personnel as needed.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities 

• Advanced organization and project management skills, including ability to lead major validation projects and/or multiple projects simultaneously. 
• Advanced troubleshooting and problem-solving skills and ability to implement creative solutions to problems.
• Ability to maintain gowning requirements as needed to access controlled areas.
• Ability to work both independently and in conjunction with a team.
• Proficient knowledge of MS Office.
• Proficient knowledge of GMP regulations and validation guidelines, including 21 CFR Part 11.  
• Excellent oral and written communication skills.
• Ability to mentor and train junior associates in validation principles.
• Ability to apply statistical analysis tools to designs of experiment and sampling methods.

Core Values

• The Validation Engineer III is expected to operate within the framework of Tolmar’s Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success, and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company’s success.
• Go the extra mile to make things happen.
• Be committed,,  to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients and take action with great speed and efficiency no matter the task.

 Education& Experience

• Bachelor’s degree in engineering or science related field or equivalent years of experience.
• A minimum of five (5) years of experience in the pharmaceutical industry with two (2) years of direct commissioning, qualification, validation experience.

Compensation and Benefits

• Annual pay range $95,000 - $105,000
• Bonus eligible
• Relocation benefits available 
• Benefits information: https://www.tolmar.com/careers/employee-benefits 

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. 

Working Conditions

• Working conditions are normal for an office environment.
• Work may require occasional weekend and/or evening work.
• Work inside manufacturing clean rooms where gowning is required. 

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.